NCT07046897

Analysis of the Gut Microbiota Composition After Consumption of Probiotic Bacteria

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this intervention study is to evaluate the beneficial effect of the probiotic bacterium Bacillus coagulans in healthy volunteers. The main question it aims to answer is if the probiotic strains are modifying the microbiota composition in a beneficial way, evaluated in faecal- and saliva samples. Primary hypothesis: The probiotic bacteria will modify the microbiota composition in faecal- and saliva samples. Participants will consume the freeze-dried probiotic bacteria for 14 days. Before and after consumption, the participants will collect samples.

Detailed description

Samples will be frozen immediately after collection and will be kept frozen until analysis at the Department of Process and Life Science Engineering, Faculty of Engineering, Lund University. For diversity measures, species identification and relative abundance of bacterial taxa, samples will be analysed by Illuminas MiSeq with the MiSeq reagent kit v3. Data will be analysed with bioinformatic pipeline QIIME2TM.

Conditions

• Microbiota Analysis in Healthy Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Consumption of probiotics strain 5	Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 5.
DIETARY_SUPPLEMENT	Consumption of probiotics strain 6	Consumption of probiotic capsules containing the probiotic bacteria Bacillus coagulans strain 6.

Timeline

• Start date: 2024-11-12
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: Sweden